Pharmaceutical Cosmopolitanism, Ctd

by Patrick Appel

A reader writes:

As someone who works at FDA I can say the problem with this idea is that drug companies submit their applications for approval to the US, EU and Japan at the same time. Differences in approval times generally differ by only a few months at most; when they don't there is generally an important reason why not.

Another reader adds:

Friedersdorf asks for objections to allowing drugs approved in trusted countries to be approved here. One reason should be drug companies will "forum shop" for the cheapest, easiest approval process on the list. This means if, say, Japan is more willing to approve OTC painkillers for some reason, then any concerns by American regulators about the safety or efficacy of a such drugs would be effectively ignored. Every class of drugs would be approved by the laxest board on the list, and any specific concerns about a class of drugs (e.g. does this new cox-2 inhibitor cause heart attacks?) would only be propagated to actual results in regulation when every country on the list was unanimous in its application of a certain standard.